FDA refuses to review Moderna's new mRNA flu vaccine - AP
Kyiv • UNN
The FDA has rejected Moderna's application for a new mRNA flu vaccine, citing inadequate clinical trials. The agency raised objections to the vaccine's comparison with the "best available standard of care in the US."
The American Food and Drug Administration (FDA) is refusing to consider Moderna's application for a new flu vaccine, manufactured using mRNA technology, which was awarded the Nobel Prize. This is reported by UNN with reference to Associated Press.
Details
The announcement is further evidence of the FDA's heightened scrutiny of vaccines under Health Secretary Robert F. Kennedy Jr., especially those using mRNA technology, which he criticized before and after becoming the nation's top health official.
Moderna received a so-called "refusal to file" letter from the FDA, raising objections to the 40,000-person clinical trial that compared the new vaccine to one of the standard flu vaccines used today. The trial concluded that the new vaccine was somewhat more effective for adults aged 50 and older than the standard vaccine.
At the same time, a letter from FDA vaccine director Dr. Vinay Prasad states that the agency does not consider the application to contain an "adequate and well-controlled trial" because it did not compare the new vaccine to the "best available standard of care in the U.S. at the time of the study." The same letter from Prasad pointed to some recommendations that FDA officials gave Moderna in 2024 under the Biden administration, but which Moderna did not follow.
In addition, these recommendations stated that while using the standard dose of flu vaccine chosen by the company was acceptable, for study participants aged 65 and older, it would be better to use a different brand of vaccine specifically recommended for the elderly. However, according to Moderna, the FDA agreed to allow the study to proceed as originally planned.
Recall
U.S. President Donald Trump signed an executive order banning funding for gain-of-function research that enhances pathogens.
Meanwhile, WHO member states have developed an agreement on sharing medical technologies to prepare for future pandemics. The agreement will incentivize technology transfer, but on mutually agreed terms.